Guideline on Specific Adverse Reaction Follow-Up Questionnaires (Specific AR FUQ) What is ADE FUQ? The Adverse Drug Event Follow-Up Questionnaire (ADE FUQ) is designed to provide guidance to the EU/EEA regulatory medicines network on the appropriate use of Specific Adverse Reaction Follow-Up Questionnaires (Specific AR FUQs) in routine pharmacovigilance activities, as outlined in the Good… Continue reading Guideline on Specific Adverse Reaction Follow-Up Questionnaires (Specific AR FUQ)
Category: Pharmacovigilance
Understanding Periodic Safety Update Reports (PSURs) and Their Importance in Pharmacovigilance
Understanding Periodic Safety Update Reports (PSURs) and Their Importance in Pharmacovigilance In the world of pharmaceutical regulation, ensuring the ongoing safety of medicinal products post-market approval is just as crucial as during their development. One of the most important documents used to monitor and evaluate the safety of a drug after it hits the market… Continue reading Understanding Periodic Safety Update Reports (PSURs) and Their Importance in Pharmacovigilance
FDA FAERS Electronic Submissions for Postmarketing & Premarketing ICSRs
FDA Adverse Event Reporting System (FAERS) Electronic Submissions: To assist industry when making certain regulatory submissions in electronic format to the FDA’s Adverse Event Reporting System (FAERS) database for the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
CDSCO Revised Pharmacovigilance Guidance on Extending Event Reporting Deadline
Central drug standard control organizations has released version 2.0 pharmacovigilance guidance, enacting changes such as extending the deadline for reporting non-serious adverse events and revising record-keeping requirements.